The European Medicines Agency or EMA has advised of allowing marketing to panobinostat (Farydak, Novartis), granting authorization for the treatment of multiple myeloma and sonidegib (Odomzo, Novartis) for advanced basal cell carcinoma.
The European Medicines Agency Committee for Medicinal Products for Human use has provided with the recommendations.
Panobinostat is designed and intended for patients suffering from relapsed and/or refractory multiple myeloma who have received at least two previous standard therapies which includes bortezomib (Velcade, Millennium) and an immunomodulatory agent. it is to be put to use by combining it with bortezomib and the anti-inflammatory agent dexamethasone.
Panobinostat is the first in a new category of agent which behaves as an inhibitor of histone deacetylases, which are nothing but enzymes involved in turning genes on and off within cells itself.
In a pivotal randomized study consisting of 768 patients with multiple myeloma, which is a triple-drug regimen of panobinostat added to bortezomib and dexamethasone was compared with a two-drug regimen of bortezomib and dexamethasone.
193 patients, who also are study subjects had received at least two previous treatments in the study, which includes an immunomodulatory agent and bortezomib.
The triple-drug showed appreciable progression-free survival by an average of 4.8 months, when compared with the two-drug regimen.
The most common adverse effects of panobinostat were blood disorders, hemorrhage, diarrhea, nausea, vomiting, and fatigue.
There were more serious adverse events in the group which had undergone triple drug regimen in comparison to the control group: 60 percent in comparison to 42 percent, precisely.